Alphazyme
biotechnology
Manager,QAOperations
Neural analysis suggests this role is
optimal for Mid candidates.
“Manager, QA Operations at Alphazyme. Skills: Quality Assurance, Managerial experience, ISO 13485, Regulatory compliance. Manage Quality Assurance department day to day operations. Implement training and performance management”
What You'll Achieve.
ensure adherence to production quality standards; ensure compliance with operational, statutory, and regulatory requirements; maintain QMS compliance; address CAPAs, NCs, and audit findings; monitor performance associated with Quality management; enhance success of project and maintain relationships within all parts of company; ensure that focus on growth and success of company is achieved
Industry & Context.
Demonstrated scientific “problem solving” skills
#LI-Onsite
What They're Looking For.
Must Have
Bachelor's Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline, 3-5 years of managerial experience in non-academic biotechnology related industry, 1-3 years of supervisory experience, Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
Nice to Have
Industry experience in a Good Manufacturing Practice (GMP) environment is preferred
What You'll Do.
Manage Quality Assurance department day to day operations
Implement training and performance management
Evaluate documentation and policies for compliance
Collaborate to identify and fill documentation gaps
Author and maintain quality documentation
Oversee timely reviews of work instructions
Support QC with customer complaints
Participate on core teams
Provide QA deliverables on quality processes
Implement and track metrics
Identify and implement efficiency improvement initiatives
Facilitate proactive solutions by collecting data
Manage Internal Audit Program
How You'll Work.
Team & Collaboration
Collaborate with management to identify and fill documentation and process gaps; Actively participate on core teams; Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively
Communication Scope
Excellent communication and presentation skills are required
Process & Methodology
Manage Internal Audit Program, Ensure that demanding and difficult projects are handled smoothly and cooperatively
Full Job Description
Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Manager, QA Operations. The Manager, QA Operations is responsible for the implementation of policies and procedures to ensure adherence to production quality standards and oversight of the Company’s electronic ISO 13485:2016 Quality Management System. The Quality Assurance Manager is expected to ensure compliance with operational, statutory, and regulatory requirements in support of the Company’s business objectives. How you will make an impact: Manage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reports Implement and periodically evaluate documentation and policies to ensure continuous compliance to the quality, integrity, and efficiency standards set by the organization, the ISO 13485:2016 standard, and other statutory and regulatory requirements
Applying for this Manager, QA Operations role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Alphazyme?
Real rants from real employees. Read before you apply.